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    Summary
    EudraCT Number:2010-023988-17
    Sponsor's Protocol Code Number:260777
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-04-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2010-023988-17
    A.3Full title of the trial
    Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn.
    Ovlivnění hypotenze u předčasně narozených dětí: multicentrická, randomizovaná, kontrolovaná studie ovlivnění hypotenze u novorozenců extrémně nízkého gestačního věku.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of Hypotension In the Extremely Preterm Infant
    Ovlivnění hypotenze u novorozenců extrémně nízkého gestačního věku.
    A.3.2Name or abbreviated title of the trial where available
    HIP Trial
    Studie HIP
    A.4.1Sponsor's protocol code number260777
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01482559
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/291/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBrepCo Biopharma Limited
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Commission Seventh Framework Programme (FP7)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Cork
    B.5.2Functional name of contact pointEugene Dempsey
    B.5.3 Address:
    B.5.3.1Street AddressCork University Hospital
    B.5.3.2Town/ cityWilton, Cork
    B.5.3.4CountryIreland
    B.5.4Telephone number00353870524271
    B.5.6E-mailgene.dempsey@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TENSAMIN
    D.2.1.1.2Name of the Marketing Authorisation holderZentiva, k.s., Prague, Czech Rep.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTensamin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOPAMINE HYDROCHLORIDE
    D.3.9.1CAS number 62-31-7
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive namen/a
    D.3.9.4EV Substance CodeSUB01818MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20 mcg/kil/min
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Low Blood Pressure
    Arteriální hypotenze - nízký krevní tlak
    E.1.1.1Medical condition in easily understood language
    Low Blood Pressure
    Arteriální hypotenze - nízký krevní tlak
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10024895
    E.1.2Term Low blood pressure
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether in infants born before 28 completed weeks of gestation, an observational approach to the management of hypotension compared to a standard approach using dopamine as a first line inotrope within the first 72 hrs improves:
    1. Survival free from neurodevelopmental disability at 2 years corrected gestational age (GA).
    2. Survival without significant brain injury at 36 weeks corrected GA.
    Zjistit, zda u dětí narozených pžed dokončeným 28 týdnem gestace observační přístup k ovlivnění hypotenze v porovnání se standardním přístupem využívajícím dopaminu jako inotropika prvé linie dopamine v průběhu prvních 72 hodin zlepšuje:
    1. Přežití bez neurodevelopmentálních poruch ve 2 letech korigovaného gestačního věku (GA).
    2. Přežívání bez významného poškození mozku v 36 týdnech korigovaného gestačního věku (GA).
    E.2.2Secondary objectives of the trial
    To determine whether an observational approach to the management of hypotension compared to a standard approach with dopamine affects:
    •All cause mortality at 36 weeks GA.
    •The incidence of severe abnormality (grade III-IV intraventricular haemorrhage (IVH), periventricular cystic leukomalacia or ventricular dilatation) detected on serial cranial ultrasound examinations.
    •The number of adverse effects attributable to treatment.
    •Individual impairments at 2 years.
    •Developmental and behavioural scores at 2 years.
    Zjistit, zda observační přístup k ovlivnění hypotenze v porovnání se standardním přístupem využívajícím dopaminu ovlivní:
    •Všechny případy úmrtí v 36 týdnu GA.
    •Incidenci závažných abnormalit (stupeň III-IV intraventrikulárního krvácení, periventrikulární cystické leukomalacie nebo ventrikulární dilatace) detekovaných sérií ultrazvukových vyšetření hlavy
    •Počet nežádoucích příhod, které lze připsat účinku léčby.
    •Individuální zhoršení ve dvou letech.
    •Vývojové a behaviorální skóre ve dvou letech.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Gestational age from 23 weeks at birth to less than 28 completed weeks (i.e. up to and including 27 weeks and 6 days).
    •Within 72 hours of birth.
    •An indwelling arterial line, suitably calibrated and zeroed, to monitor blood pressure.
    •A pre-trial cranial ultrasound scan free of grade III-IV IVH or cystic PVL.
    •A mean blood pressure (BP) 1 mmHg or more below a mean BP value equivalent to the GA in completed weeks, which persists over a 15 minute period.

    •Gestačné věk od 23 týdnů při narození do méně než 28 dokončených týdnů .
    •Během 72 hodin po narození.
    •Zavedený arteriální katétr, vhodně kalibrovaný a vynulovaný, k monitorování krevního tlaku.
    •Ultrazvukové vyšetření hkavy bez známek III.-IV. stupně komorového krvácení nebo cystické PVL.
    •Průměrná hodnota krevního tlaku 1 mmHg nebo více pod průměrnou hodnotou odpovídající gestačnímu věku v dokončených týdnech, který přetrávává více než 15 minut.

    E.4Principal exclusion criteria
    • Infant is considered non-viable by attending clinicians.
    • Life-threatening congenital abnormalities including congenital heart disease and chromosomal abnormalities.
    • Infants known to require surgical treatment.
    • Hydrops Fetalis.
    • Dítě je pokládáno ošetřujícím lékařem za neživotaschopné.
    • Vozené odchylky ohrožujíí na životě včetně vrzeného srdečního onemocnění a chromozomálních odchylek.
    • Děti vyžadující chirugickou léčbu.
    • Hydrops plodu.
    E.5 End points
    E.5.1Primary end point(s)
    Survival free from neurodisability at 2 years corrected GA.

    Survival to 36 weeks corrected GA free of severe brain injury on 36 week cranial ultrasound.
    Přežívání bez projevů neurodisability ve dvou letech korigovaného gestačního věku.

    Přežívání do 36. týdne korigovaného gestačního věku bez závažného poškození mozku ve 36. týdnu dle ultrazvukového vyšetření.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Survival free from neurodisability at 2 years corrected gestational age

    Survival to 36 weeks corrected GA free of severe brain injury on 36 week cranial ultrasound.
    Přežívání bez projevů neurodisability ve dvou letech korigovaného gestačního věku.

    Přežívání do 36. týdne korigovaného gestačního věku bez závažného poškození mozku ve 36. týdnu dle ultrazvukového vyšetření.
    E.5.2Secondary end point(s)
    All cause of mortality at 36 weeks corrected gestational age

    All cause of mortality before first discharge home.

    Recording and reporting of any Adverse Events.
    Všechny případy úmrtí ve 36. týdnu korigovaného gestačního věku.

    Všechny případy úmrtí před prvým propuštěním do domácí péče.

    Záznam a hlášení jakékoliv nežádoucí příhody.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 weeks corrected gestational age
    36. týden korigovaného gestačního věku.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Neurological assessment at 24 months corrected GA.
    Neurologické posouzení ve 24 měsících korigovaného gestačního věku
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 830
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 830
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Extreme Preterm Infants.
    Parents/guardians will be approached for consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state285
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 570
    F.4.2.2In the whole clinical trial 830
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    (Families will be offered routine appointments. At 12-months, the clinician will complete a simple disability assessment to provide interim data should the infant be subsequently lost to follow up (LTFUp). All surviving infants in the study will have a locally performed formal neurodisability assessment at 24 months of age corrected for weeks of prematurity)
    Neuvádí se.
    (Rodinám budou nabídnuty běžné návštěvy lékaře. Ve 12 měsících provede lékař jednoduché posouzení omezení, aby získasl prozatímní údaje pro případ, že by se dítě ztratilo z dalšího sledování. Všechny přežívající děti ve studii podstoupí formálním posouzením neurodisability v místě studie ve 24 měsících věku korigovaného na týdny nezralosti).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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